MAUDE Adverse Event Report: AESCULAP AG MINOP ANGLED ENDOSCOPE 0DEG180MM 2.7MM; NEUROENDOSCOPY

Model Number PE184A

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional to the company sales representative "the surgeon and tech could not get a good image through the scope.Per the account, they switched to the pedi version; towers, light cords, cameras, and monitors attempting to get a working image.Scope was not inserted into patient.The patient was not under anesthesia at the time, but the case was delayed while the team opened the other scope and got set up." there was a 15 minute delay in surgery.No additional intervention needed.No serious injury or death.

Manufacturer Narrative

Investigation: no product is at hand.Batch history review: the device quality and manufacturing history records have been checked for all the lot numbers and found to be according to the specification, valid at the time of production.Conclusion and root cause: no product available and therefore it is not possible to determine an exact conclusion and root cause.Rationale: unfortunately due to a lack of data and without the product, we can not determine the exact cause.If further investigations are required, the product should be provided for examination.According to the quality standard and dhr files, a material defect or production error can be excluded.There is the possibility for an improper handling due to bent light cords, damage due to an incorrect handling by cleaning/ disinfection or sterilization and there is also the possibility for an improper maintenance.No capa is necessary.

• Brand Name: MINOP ANGLED ENDOSCOPE 0DEG180MM 2.7MM
• Type of Device: NEUROENDOSCOPY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8052881
• MDR Text Key: 126658174
• Report Number: 9610612-2018-00496
• Device Sequence Number: 1
• Product Code: GWG
• Combination Product (y/n): N
• PMA/PMN Number: K983365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PE184A
• Device Catalogue Number: PE184A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/13/2018
• Date Manufacturer Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1